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<p>Prenatal diagnosis is a vital component of maternal–fetal medicine, enabling early detection of genetic, chromosomal, and structural anomalies with increasing accuracy. Over recent decades, diagnostic methods have evolved from traditional invasive procedures to advanced non-invasive prenatal testing (NIPT), high-resolution imaging, and integrated multi-omics platforms, substantially improving diagnostic precision while minimizing risks to both mother and fetus. This systematic review, based on an analysis of over 400 research articles and reviews, comprehensively examines technological advancements alongside the concurrent development of regulatory frameworks shaping prenatal diagnostics. The findings underscore that while technology advances rapidly, ensuring reliability, clinical validity, and safety remains critical. Regulatory frameworks, especially the European Union’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), serve as fundamental standards that diagnostic device manufacturers must comply with to balance innovation with ethical responsibilities, patient safety, and public trust. In conclusion, revolutionary advancements in prenatal diagnostic technologies have made early screening more precise, accessible, and patient-friendly. Adherence to evolving regulations mitigates ethical concerns and safeguards diagnostic efficacy, ultimately enabling safer prenatal diagnosis, facilitating informed pregnancy management decisions, and reducing emotional and financial burdens on expectant families.</p>

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Advancements in prenatal diagnostics and the effects of EU regulatory frameworks, including the IVDR and MDR: A systematic review

  • 期刊论文

  • 出版模式：

    开放获取

  • 发表日期：

    2025年10月10日

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  • Ravi Adusumalli,
  • Rajkiran Reddy Banala

摘要

Prenatal diagnosis is a vital component of maternal–fetal medicine, enabling early detection of genetic, chromosomal, and structural anomalies with increasing accuracy. Over recent decades, diagnostic methods have evolved from traditional invasive procedures to advanced non-invasive prenatal testing (NIPT), high-resolution imaging, and integrated multi-omics platforms, substantially improving diagnostic precision while minimizing risks to both mother and fetus. This systematic review, based on an analysis of over 400 research articles and reviews, comprehensively examines technological advancements alongside the concurrent development of regulatory frameworks shaping prenatal diagnostics. The findings underscore that while technology advances rapidly, ensuring reliability, clinical validity, and safety remains critical. Regulatory frameworks, especially the European Union’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), serve as fundamental standards that diagnostic device manufacturers must comply with to balance innovation with ethical responsibilities, patient safety, and public trust. In conclusion, revolutionary advancements in prenatal diagnostic technologies have made early screening more precise, accessible, and patient-friendly. Adherence to evolving regulations mitigates ethical concerns and safeguards diagnostic efficacy, ultimately enabling safer prenatal diagnosis, facilitating informed pregnancy management decisions, and reducing emotional and financial burdens on expectant families.